BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 1874555 · Received October 19, 2010

    Report

    Report Number
    6000094-2010-02043
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE "MALFUNCTIONED". THE DEVICE WAS EXPLANTED AND REPLACED. A FEW DAYS AFTER THE DEVICE WAS REPLACED, THE PATIENT REPORTED RETURNING TO THE HOSPITAL DUE TO "BACTERIA IN THE BLOOD". THE PATIENT ALSO REPORTS FEELING "PAIN ALL OVER", AND "SEVERE PAIN IN THE NECK, SHOULDERS, AND FEET". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR ASKU LWS MEDTRONIC S.A. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD